Apneic Oxygenation for Morbid Obese Parturient in cs
Effectiveness of Apneic Oxygenation for Morbid Obese Parturient Performing Elective Caesarean Section Under General Anesthesia
1 other identifier
interventional
60
1 country
2
Brief Summary
The aim of this study is to compare the effect of apneic preoxygenation to conventional preoxygenation on the oxygen desaturation in morbid obese parturient performing elective caesarean section under general anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2021
CompletedFirst Posted
Study publicly available on registry
August 25, 2021
CompletedStudy Start
First participant enrolled
September 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2022
CompletedJune 7, 2022
June 1, 2022
7 months
August 20, 2021
June 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
the lowest oxygen saturation recorded
percentage
during intubation procedure
Secondary Outcomes (2)
rates of desaturation below SpO2 90%
during intubation procedure
rates of critical desaturation below SpO2 80%
during intubation procedure
Study Arms (2)
nasal prong.
ACTIVE COMPARATORthe apneic preoxygenation group (30 patients), will receive 10 L/ min of O2 via nasal prong.
conventional
NO INTERVENTIONthe conventional preoxygenation group (30 patients)
Interventions
apneic preoxygenation group (30 patients), will receive 10 L/ min of O2 via nasal prong during preintubation apnia
Eligibility Criteria
You may qualify if:
- Morbid obesity parturient defined as a body mass index (BMI) above 40 kg/m2.
- ASA physical status I-II
- Age above 18 years.
- Scheduled for elective caesarean section under general anesthesia.
You may not qualify if:
- Parturient of ASA physical status III or above.
- Suspected or known difficult airway (Mallampati class \> 2, reduced neck movement, reduced mouth opening, or Cormack-Lehane grade 4 recorded during a previous intubation procedure).
- Any contraindication for nasal prong use, for example, tumours, fractures or trauma.
- SpO2 ≤ 97% prior to preoxygenation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ain Shams university
Cairo, 11591, Egypt
Faculty of medicine
Cairo, 11591, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
August 20, 2021
First Posted
August 25, 2021
Study Start
September 15, 2021
Primary Completion
April 1, 2022
Study Completion
April 10, 2022
Last Updated
June 7, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- after finishing the study
- Access Criteria
- clinicaltrial web site
all IPD to be shared